Is use of antiretroviral treatment (ART) associated with decreased condom use? A meta-analysis of studies from low- and middle-income countries (LMICs)C. Kennedy1, K. Armstrong2, V. Fonner1, M. Sweat2, K. O'Reilly21Johns Hopkins Bloomberg School of Public Health, International Health, Baltimore, United States, 2Medical University of South Carolina, Psychiatry and Behavioral Sciences, Charleston, United States

This Abstract-Driven
Session presented five important studies
about the preventive effects of treatment (and perceptions around this), in
various settings and populations.

In the first presentation, “From
efficacy to effectiveness: ART uptake and HIV seroincidence by ART status among
HIV discordant couples in Zambia”, by Kristin Wall, it was concluded that ART uptake among HIV+ individuals in discordant relationships was low. The
CIDA-funded Couples VCT (CVCT) expansion led to testing of more couples over a
shorter period of time relative to other regions and a significantly higher
follow-up rate that allowed for seroincidence estimates. If was found that ART
effectiveness in the cohort was much lower than in randomized trials likely due
to access and adherence issues. Given reduced HIV transmission rates in
discordant couples after CVCT irrespective of ART, CVCT with follow-up testing
for discordant couples, an effective and locally affordable prevention
intervention, should be provided and promoted in government clinics.

The second presentation, “Evidence of
behavioural risk compensation in a cohort study of HIV treatment and
transmission in homosexual male serodiscordant couples”,by Ben Bavinton
(Australia), among MSM in the Opposites Atract study, showed that among Australian HIV-negative men in
homosexual male serodiscordant couples, perceiving the partner''s VL to be
undetectable was associated with increased practice of UAI, and this
association persisted over time. We have documented behavioural risk
compensation but no HIV seroconversion in this cohort of homosexual male SDCs.
It was suggested that studies of the efficacy of HIV treatment as prevention in
homosexual male populations are a research priority.

The third presentation, “What is this 'Universal Test and Treat' (UTT)?” Community
understandings of key concepts linked to a combination HIV prevention strategy
in 21 Zambian and South African communities”, by Virginia Bond
(Zambia), focused on understandings of prevention (and particularly ARV-based
prevention) in 21 African community sites, found that UTT and Treatment
as Prevention (TasP) were not yet familiar concepts in the 21 community sites.
Most people welcomed such prevention strategies ''in principle''; but health
system barriers and sustainable implementation were common reservations.
Implementers of UTT and TasP must work to revisit these interchangeable
concepts, building on evident community support for PMTCT.

The fourth presentation, “Is use of antiretroviral treatment (ART) associated
with decreased condom use? A meta-analysis of studies from low- and
middle-income countries (LMICs)”, by Caitlin Kennedy, was a systematic review of
condom use among people livin with HIV in relation to ARV use. This review,
which found that most studies on this topic have been conducted in the past 5
years, concluded that in LMIC, PLHIV on ART are more likely to
report condom use than those not on ART. The authors described this as
encouraging news for continued expansion of ART programs in LMICs, which
suggested that “treatment as prevention” may be true in more ways than one.

The fifth presentation, “Feasibility and acceptability of an antiretroviral treatment as
prevention (TasP) intervention in rural South Africa: results from the ANRS
12249 TasP cluster-randomised trial”, presented by Collins
Iwuji (South Africa), reported on a study wherethree six-monthly rounds of home-based HIV testing were undertaken in 10
(2x5) clusters of ~1,000 adults each (03/12-03/14) in that country. Trial
participants were offered rapid HIV testing and provided a dried blood spot
(DBS), and HIV+ participants were referred to the cluster trial clinic.The study concluded that the
home-based HIV testing strategy and TasP intervention as piloted could decrease
HIV incidence at population level. Enrolment is thus expanding to an additional
2x6 clusters from May 2014; all 22 clusters will be followed until June 2016 to
estimate the population impact of TasP on HIV incidence.

All studies generated questions from the
public, and generally showed enthusiasm about the preventive effects of
treatment. Discussion also showed that expectations about consequences of viral
suppression in serodiscordant couples do not necessarily consider acceptable that
some people (or couples) choose to use low viral loads as a prevention
strategy. It also showed that many concepts, and also many terms, related to
treatment as prevention, are controversial ad/or unstable in current discussions
about HIV prevention.

Track C report by Frederick Altice

Maximizing
the Preventive Benefits of Treatment: Evolving Views

The session was lively and included
divergent data on the impact of TasP in HIC versus LMICs, perhaps due to the
increased understanding of what TasP really is. Importantly, there was a discussion about whether the term TasP should be used to avoid any real or perceived conflict between treatment and prevention. One side suggested that TasP was stigmatizing for PLWH by blaming them for not reducing HIV transmission, while the alternative suggested that we be accurate about defining and explaining that TasP benefits the patient, their sexual partner, the healthcare system and society through documented benefits. What is clearly needed is better education about what TasP really is and what it does (part of a combination prevention strategy) and how to use positive message frames when describing it.

K
Wall S. presented intriguing
modeling data of TasP data, including cost, from <150,000 couples in Zambia
where individuals underwent couples-based VCT (CVCT), followed by TasP for the HIV+
partner within serodiscordant couples. Though
questions were raised about the parameters that were selected for HIV incidence
and the lack of incorporation of non-primary partners, there was a 82% risk
reduction for CVCT compared to 69% reduction for TasP followed by CVCT. Though not discussed, the TasP arm resulted
in a markedly lower HIV incidence compared to CVCT alone (0.44% vs 2.0%). The
cost of averting one HIV infection using CVCT was estimated to be $392 (not
sure how this relates to income and per capita health costs in Zambia). Costs to avert HIV, however, were estimated
to increase to $666 if the HIV+ partner was on ART before CVCT due to only an
estimated 30% reduction in HIV incidence. One conclusion was that for couples
(not individuals) that CVCT would ultimately lead to a higher reduction in
incidence and at a relatively low cost than TasP where the couple is not HIV
tested and counseled together (additional benefit from doing the counseling and
disclosure together).

B. Bavinton presented preliminary data from the
Australian (high income country) sample of a larger study TasP of 124 serodiscordant
MSM couples (Opposites Attract Cohort).
The study sought to explore whether the “perception” by the HIV- partner
that the HIV+ partner was non-detectable resulted in UAI (defined as risk
compensation). The sample was primarily
gay-identified, over 50% were university educated and about half had sex with
men outside their primary relationship. Most HIV+ partners were taking ART
(89.5%) and 72.9% has maximal viral load suppression, but 90% had a VL<400. There was high concordance between the HIV-
partner’s perception of their partner being non-detectable (ND) with laboratory
findings. About two-thirds of couples
reported UAI at baseline, which did not change over time. UAI was further categorized for the HIV-
partner as insertive (58.9%), receptive + withdrawal upon ejaculation (37.9%),
and receptive + ejaculation (18.6%). Using
time-dependent GEE analysis, having UAI, irrespective of being insertive or
receptive partner conferred about a 2-fold association with the perception that
the HIV+ partner had a ND VL. Though
there was some debate whether this should be called “risk compensation”, the
findings from this study in a high income setting with highly educated MSM that
individuals make decisions about sexual activities based on the perception that
they are at markedly reduced risk for acquiring (or transmitting) HIV. Not discussed was how this translated to sex
outside the primary relationship and whether participants had a working
framework about whether a ND (or markedly low) VL conferred a reduced risk for
transmitting HIV.

V. Bond presented data on the formative planning for HPTN 071 (PopART), which
is alarge-scale 3-arm, community-randomised controlled trial of a
multi-component HIV prevention intervention (including earlier access to ART)
in 21 community sites in Zambia (N=12) and South Africa (N=9), which built on a Universal Test and
Treat (UTT) model, underscored by TasP paradigm. Focus groups and key informant interviews
were conducted with >750 individuals at all sites to explore the local
context for “what does prevention mean”?
Though there were some common themes, including PMCTC, VCT, and ABC, it
was concerning that the context was profoundly different for the two countries
and that a large population-based prevention trial was about to be conducted in
a setting where concepts like universal test and treat and TasP were not even
understood as prevention and the notion that testing should be linked to
treatment was not at all understood. It
is the reminder that researchers from high income countries that ethically
before they introduce interventions that are poorly understood, they must raise
the bar for potential participants and truly provide “informed” decision-making
in a setting where the very intervention that is proposed needs considerable
explanation and understanding before study participants are enrolled. It was not surprising that the term that
researchers use (e.g., UTT, TasP, PrEP) were not part of the public vernacular
because despite them being used by researchers routinely (including at this
conference), there has been a failure by researchers, implementers and communities
to filter down information that is understandable. While it is seductive to speculate that we
should rename some of our evidence-based practices (e.g., TasP, PrEP, etc) as
something else, the more informed strategy is to educate participants and
provide the appropriate message frame for it to potential consumers (e.g., TasP
is a method to not only improve individual help, but to potentially improve the
lives of your sexual partners, the community and society).

C.
Kennedy conducted a
meta-analysis of whether patients on ART in LMICs self-reported decreased
condom use. Using data from 1990, data
consistently showed that condom use was NOT decreased for patients on ART,
despite partner type and gender. PLWH
were 1.8-fold more likely to report consistent condom use and 2.3-fold more
likely to report condom use during last sexual encounter. Aside from 3 studies (of 35), all were
published after 2007 and an update to June 2014 found a total of 50 eligible
papers. When asked why these findings
diverged from findings from Australia (see Bavinton et al), it was speculated
that there was just insufficient knowledge about TasP in LMIC and the
prevention messages propagated in these settings (see Bond et al) do not
represent contemporary scientific thinking and mostly reflect outdated and
often judgmental prevention messages. It
was further speculated that as individuals become more informed about the
potential benefit of TasP, that condom use levels may change similarly to
findings from high-income countries.

C.
Iwuji presented
preliminary findings on the feasibility and acceptability of a TasP
intervention in Kwazulu Natal in preparation for the conduct of a
cluster-randomized controlled trial (ANRS 12249). Data were reported for Phase
I of the trial to confirm pre-planned parameters estimated for the initial
conduct of the study. The details of the
study design and intervention were delineated.
Using GPS to identify households, members underwent home-based HIV
testing with HIV+s being referred immediately to HIV care and HIV-s underwent
semi-annual HIV testing. HIV+s are randomized to control (ART if CD4<350) or
intervention (ART for any CD4). Of the
~13,000 registered households, 77.5% were successfully contacted, of which
82.3% were HIV tested. Linkage to HIV
care, however, was lower than expected with only 31.2% of HIV+s being linked to
care. For initial HIV-s, repeat HIV
testing was 62.7% at second contact. Most
assumptions were verified with empirical data, except linkage to HIV care,
which often took >6 months (which had not been planned), but justifies
moving to Phase II.

Track C report by Frederick Altice

Maximizing
the Preventive Benefits of Treatment: Evolving Views

The session was lively and included
divergent data on the impact of TasP in HIC versus LMICs, perhaps due to the
increased understanding of what TasP really is. Importantly, there was a discussion about whether the term TasP should be used to avoid any real or perceived conflict between treatment and prevention. One side suggested that TasP was stigmatizing for PLWH by blaming them for not reducing HIV transmission, while the alternative suggested that we be accurate about defining and explaining that TasP benefits the patient, their sexual partner, the healthcare system and society through documented benefits. What is clearly needed is better education about what TasP really is and what it does (part of a combination prevention strategy) and how to use positive message frames when describing it.

K
Wall S. presented intriguing
modeling data of TasP data, including cost, from <150,000 couples in Zambia
where individuals underwent couples-based VCT (CVCT), followed by TasP for the HIV+
partner within serodiscordant couples. Though
questions were raised about the parameters that were selected for HIV incidence
and the lack of incorporation of non-primary partners, there was a 82% risk
reduction for CVCT compared to 69% reduction for TasP followed by CVCT. Though not discussed, the TasP arm resulted
in a markedly lower HIV incidence compared to CVCT alone (0.44% vs 2.0%). The
cost of averting one HIV infection using CVCT was estimated to be $392 (not
sure how this relates to income and per capita health costs in Zambia). Costs to avert HIV, however, were estimated
to increase to $666 if the HIV+ partner was on ART before CVCT due to only an
estimated 30% reduction in HIV incidence. One conclusion was that for couples
(not individuals) that CVCT would ultimately lead to a higher reduction in
incidence and at a relatively low cost than TasP where the couple is not HIV
tested and counseled together (additional benefit from doing the counseling and
disclosure together). One factor that was central to the findings in Africa is that among HIV serodiscordant couples, 21% of HIV+ partners were already taking ART, often without the partner's knowledge of HIV status or ART prescription (non-disclosure issue). This translated to the reduction in HIV incidence observed in HIV- partners was a combination of CVCT and ART in reducing the HIV+ partners ability to transmit virus.

B. Bavinton presented preliminary data from the
Australian (high income country) sample of a larger study TasP of 124 serodiscordant
MSM couples (Opposites Attract Cohort).
The study sought to explore whether the “perception” by the HIV- partner
that the HIV+ partner was non-detectable resulted in UAI (defined as risk
compensation). The sample was primarily
gay-identified, over 50% were university educated and about half had sex with
men outside their primary relationship. Most HIV+ partners were taking ART
(89.5%) and 72.9% has maximal viral load suppression, but 90% had a VL<400. There was high concordance between the HIV-
partner’s perception of their partner being non-detectable (ND) with laboratory
findings. About two-thirds of couples
reported UAI at baseline, which did not change over time. UAI was further categorized for the HIV-
partner as insertive (58.9%), receptive + withdrawal upon ejaculation (37.9%),
and receptive + ejaculation (18.6%). Using
time-dependent GEE analysis, having UAI, irrespective of being insertive or
receptive partner conferred about a 2-fold association with the perception that
the HIV+ partner had a ND VL. Though
there was some debate whether this should be called “risk compensation”, the
findings from this study in a high income setting with highly educated MSM that
individuals make decisions about sexual activities based on the perception that
they are at markedly reduced risk for acquiring (or transmitting) HIV. Not discussed was how this translated to sex
outside the primary relationship and whether participants had a working
framework about whether a ND (or markedly low) VL conferred a reduced risk for
transmitting HIV.

V. Bond presented data on the formative planning for HPTN 071 (PopART), which
is alarge-scale 3-arm, community-randomised controlled trial of a
multi-component HIV prevention intervention (including earlier access to ART)
in 21 community sites in Zambia (N=12) and South Africa (N=9), which built on a Universal Test and
Treat (UTT) model, underscored by TasP paradigm. Focus groups and key informant interviews
were conducted with >750 individuals at all sites to explore the local
context for “what does prevention mean”?
Though there were some common themes, including PMCTC, VCT, and ABC, it
was concerning that the context was profoundly different for the two countries
and that a large population-based prevention trial was about to be conducted in
a setting where concepts like universal test and treat and TasP were not even
understood as prevention and the notion that testing should be linked to
treatment was not at all understood. It
is the reminder that researchers from high income countries that ethically
before they introduce interventions that are poorly understood, they must raise
the bar for potential participants and truly provide “informed” decision-making
in a setting where the very intervention that is proposed needs considerable
explanation and understanding before study participants are enrolled. It was not surprising that the term that
researchers use (e.g., UTT, TasP, PrEP) were not part of the public vernacular
because despite them being used by researchers routinely (including at this
conference), there has been a failure by researchers, implementers and communities
to filter down information that is understandable. While it is seductive to speculate that we
should rename some of our evidence-based practices (e.g., TasP, PrEP, etc) as
something else, the more informed strategy is to educate participants and
provide the appropriate message frame for it to potential consumers (e.g., TasP
is a method to not only improve individual help, but to potentially improve the
lives of your sexual partners, the community and society).

C.
Kennedy conducted a
meta-analysis of whether patients on ART in LMICs self-reported decreased
condom use. Using data from 1990, data
consistently showed that condom use was NOT decreased for patients on ART,
despite partner type and gender. PLWH
were 1.8-fold more likely to report consistent condom use and 2.3-fold more
likely to report condom use during last sexual encounter. Aside from 3 studies (of 35), all were
published after 2007 and an update to June 2014 found a total of 50 eligible
papers. When asked why these findings
diverged from findings from Australia (see Bavinton et al), it was speculated
that there was just insufficient knowledge about TasP in LMIC and the
prevention messages propagated in these settings (see Bond et al) do not
represent contemporary scientific thinking and mostly reflect outdated and
often judgmental prevention messages. It
was further speculated that as individuals become more informed about the
potential benefit of TasP, that condom use levels may change similarly to
findings from high-income countries.

C.
Iwuji presented
preliminary findings on the feasibility and acceptability of a TasP
intervention in Kwazulu Natal in preparation for the conduct of a
cluster-randomized controlled trial (ANRS 12249). Data were reported for Phase
I of the trial to confirm pre-planned parameters estimated for the initial
conduct of the study. The details of the
study design and intervention were delineated.
Using GPS to identify households, members underwent home-based HIV
testing with HIV+s being referred immediately to HIV care and HIV-s underwent
semi-annual HIV testing. HIV+s are randomized to control (ART if CD4<350) or
intervention (ART for any CD4). Of the
~13,000 registered households, 77.5% were successfully contacted, of which
82.3% were HIV tested. Linkage to HIV
care, however, was lower than expected with only 31.2% of HIV+s being linked to
care. For initial HIV-s, repeat HIV
testing was 62.7% at second contact. Most
assumptions were verified with empirical data, except linkage to HIV care,
which often took >6 months (which had not been planned), but justifies
moving to Phase II.